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Brexpiprazole oral fast dissolving film

A technology of oral instant dissolving film and ebiprazole, which is applied in the field of ebiprazole orally disintegrating tablets and its preparation, can solve the problems of unfavorable schizophrenic patients' compliance, the preparation is fragile, and it is in the blank, so as to improve the Effects of bioavailability, realization of pregastric absorption, and improvement of compliance

Inactive Publication Date: 2016-03-16
BEIJING KANG LISHENG PHARMA TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this technology is relatively cumbersome, and the prepared preparation is easily broken, which is not suitable for transportation, and it cannot be wet when taking it, which increases the requirements for patients and is not conducive to the compliance of schizophrenia patients.
Simultaneously, ebiprazole is prepared into an oral instant film, which is still in the blank in the prior art

Method used

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  • Brexpiprazole oral fast dissolving film
  • Brexpiprazole oral fast dissolving film
  • Brexpiprazole oral fast dissolving film

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Ebiprazole oral instant film is prepared from the following components, and the dosage is 1000 tablets:

[0027]

[0028] First add the above-mentioned amount of acesulfame-K, glycerin and polysorbate 80 into the aqueous solution, stir to dissolve, then add hypromellose, fully stir and dissolve to obtain hypromellose blank glue, then add ibiprazole and stir until uniformly dispersed to obtain ebiprazole drug-containing glue, stir and defoam under vacuum conditions, apply the drug-containing glue evenly on the polyester tape after defoaming, heat and dry at 70-80°C, and dry After that, it is white, the toughness and strength are slightly poor, and it cannot be formed into a film.

Embodiment 2

[0030] Ebiprazole oral instant film is prepared from the following components, and the dosage is 1000 tablets:

[0031]

[0032] First add the above-mentioned amount of acesulfame-K, glycerin and polysorbate 80 into the aqueous solution, stir to dissolve, then add hypromellose, fully stir and dissolve to obtain hypromellose blank glue, then add ibiprazole and stir until uniformly dispersed to obtain ebiprazole drug-containing glue, stir and defoam under vacuum conditions, apply the drug-containing glue evenly on the polyester tape after defoaming, heat and dry at 70-80°C, and dry After that, it is white, the toughness and strength are slightly poor, and it cannot be formed into a film.

Embodiment 3

[0034] Ebiprazole oral instant film is prepared from the following components, and the dosage is 1000 tablets:

[0035]

[0036] First add the above-mentioned amount of acesulfame-K, glycerin and polysorbate 80 into the aqueous solution, stir to dissolve, then add hypromellose, fully stir and dissolve to obtain hypromellose blank glue, then add ibiprazole And stir until it is evenly dispersed to obtain the ebiprazole drug-containing glue, stir and defoam under vacuum conditions, apply the drug-containing glue evenly on the polyester tape with a scraper after defoaming, heat and dry at 70-80°C, dry After that, it is white, the toughness and strength are slightly poor, and it cannot be formed into a film.

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Abstract

The invention relates to a brexpiprazole oral fast dissolving film which can be dissolved instantly in the oral cavity and is used for improving a using property of brexpiprazole, and belongs to the field of medicinal preparations. The brexpiprazole oral fast dissolving film includes a medicine active ingredient and auxiliary materials applicable to pharmacy. Brexpiprazole is adopted as the medicine active ingredient. The auxiliary materials applicable to the pharmacy include a film forming material, plasticizer, an absorption enhancer, a flavoring agent and the like. The brexpiprazole oral fast dissolving film has the advantages of being large in drug-loading capacity, small in thickness, good in mouthfeel, capable of being dissolved in the oral cavity instantly without drinking water, and high in oral absorption speed, solves the problems that severe depression patients and schizophrenia patients are poor in medicine taking compliance, hide medicine and vomit the medicine, and is particularly suitable for the patients with dysphagia.

Description

technical field [0001] The invention relates to a pharmaceutical preparation in the category of oral rapid release, in particular to an orally disintegrating ebiprazole tablet and a preparation method thereof. Background technique [0002] As a 5-HT1A receptor and dopamine D2 receptor agonist and a 5-HT2A receptor antagonist, Ebiprazole Tablets are clinically used for the treatment of severe depression and schizophrenia. For the treatment of severe depression, the initial dose is 0.5mg / day or 1mg / day, and then increased to the target dose of 2mg, once a day, the maximum recommended dose is 3mg / day; for the treatment of schizophrenia, the initial dose 1mg / day, the recommended target dose is 2mg to 4mg, once a day, the maximum recommended dose is 4mg / day. Ebiprazole has a wide range of activities in multiple monoamine systems, the partial agonist activity of dopamine D2 receptors is reduced, and the specific 5-HT receptors (such as 5-HT1A, 5-HT2A, 5-HT7) The improved affinit...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/496A61K47/38A61K47/36A61K47/42A61P25/18A61P25/24
CPCA61K9/006A61K9/7007A61K31/496A61K47/36A61K47/38A61K47/42
Inventor 程刚
Owner BEIJING KANG LISHENG PHARMA TECH DEV
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